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The European Falsified Medicines
Directive
By
Lisa Miller
NPA Pharmacist Advisor
Aims and objectives
• What is the European Falsified Medicines
Directive (FMD)?
• When will FMD come into effect?
• How will it affect community pharmacy?
• FAQs
• NPA resources
• Questions
Falsified medicines: the facts
• Approximately 100,000 deaths a year occur due to
falsified medicines
• Approximately 30,000 illegal pharmacy websites
• Most common falsified medicines include hormones,
steroids and medicines for HIV/AIDs
Fake medicines that are passed off as real,
authorised medicines
Falsified medicines: the facts
• Falsified medicines may:
– Be fraudulently mislabelled
– Contain low quality ingredients
– Contain the wrong dose
– Contain wrong ingredients
– Have fake packaging
• Falsified medicines do not pass efficacy, evaluation,
quality and safety required for EU authorisation and
MHRA authorisation
Falsified vs. counterfeit
Counterfeit medicines: medicines that do not
comply with intellectual-property rights or that infringe trademark law
Falsified medicines: fake medicines that are designed to mimic real
medicines
FMD: background
• Approved by European Parliament
• Two mandatory safety features
• Allows medicines to be verified and
authenticated
• To be implemented from 9 February 2019
– The impact of Brexit is currently unknown
Aims to prevent falsified medicines entering the
supply chain
FMD: background
• FMD requires :
– Mandatory safety features on medicine packaging;
an anti-tamper device (ATD) and unique
identifier (UI) in the form of a 2D barcode
– All online pharmacies register and display an EU
wide logo
– Restrictions on the import of active ingredients
– Heightened record keeping requirements for
wholesalers
Enforcement and monitoring
• Update legislation and set penalties
Department of Health
• Enforcement for manufacturers and wholesalers
Medicines and Healthcare products Regulatory
Agency (MHRA)
• Enforcement for community pharmacies
General Pharmaceutical Council (GPhC) and
Pharmaceutical Society of Northern Ireland (PSNI)
National Medicines Verification
System (NMVS)
• Each EU member state has a National
Medicines Verification Organisation
(NMVO).
• The NMVO runs the NMVS
• The UK’s NMVO is SecurMed UK
• Does not track and trace
FMD medicine safety features
Verifying and authenticating medicinesManufacturers enter each medicines UI code to the National Medicines Verification System (SecurMed UK)
Pharmacies will be required to authenticate medicines “at the time of supplying it to the public”
This includes checking the ATD is still intact
And scanning the UI on the medicines outer packaging – referred to as ‘decommissioning’
Verifying and authenticating medicines• There are two potential messages displayed once the
UI has been scanned:
• Medicine can be dispensed as long as the ATD is undamaged
• If the ATD is broken in order to dispense the medicine, this is exempt
• Successfully decommissioned
“Active”
• Cannot be supplied
• Additional messages include “already dispensed”, “recalled”, “withdrawn”, “stolen” or “locked”
“Inactive”
Decommissioned medicines
• Decommissioned medicine status change from:
• If the product is not supplied, the status can be
reversed
“Active”“Inactive –dispensed”
Reversing the medicine status• Reversing the “decommissioned” status of a medicine
can only occur if:
– It takes place at the same pharmacy it was
decommissioned
– It occurs no more than 10 days after
decommissioning
– The product has not expired
– The product has not been recalled, withdrawn,
stolen or intended for destruction
– The medicine has not been supplied to a patient
Implications for pharmacy contractors
• All community pharmacies will be required
to:
– Connect to the UK National Medicines
Verification System
– Update software
– Obtain scanners
– Introduce SOPs
Scanning and decommissioning
medicines
• ‘Aggregated barcodes’ may can be used where
more than one medicine is dispensed
– This code links multiple items together and allows
decommissioning of all items in one go by scanning the
aggregated code on the bag label
• ‘10 day’ rule
“At the time of supplying it to the public” is not defined
but the FMD process must be completed before the
medicine is released to the patient
Split packs and MDS
• Check the ATD and scan UI when first opening a pack
• Remainder of pack does notrequire further checks before use
Split packs
• Before dispensing into an MDS, ATDs must be checked and UI scanned to decommission the product
MDS
Potential decommissioning points
During assembly
During accuracy check
At point of hand out
At point of hand out with aggregated code
Decommissioning points and patient
safety concerns
• Additional step/increase workload
• Time period between assembly and handing out
• Increased pressure/distraction
During assembly
or
during accuracy
check
Decommissioning points and patient
safety concerns
• Prescription bags need to be re-opened
• Training required for all support staff
• Increased workload/pressure
At point of hand out
with/without aggregated
code
FAQs
How close are we to implementing FMD?
• The UK FMD Working Group for Community
Pharmacy work ongoing to ensure the
implementation within the time frame
• Brexit – questions over how Brexit will affect the
implementation of FMD
• 9th February 2019 - FMD
• 29th March 2019 - Brexit
Do GSL and P medicines need to be
decommissioned before supplying?
• Non-prescription medicines are not included
under FMD
• Therefore do not require decommissioning
– The only exception is OTC omeprazole
• Unlicensed specials and appliances/devices do
not require decommissioning
How do I deal with medicines that do not
have a UI code?
• There may be medicines in the supply chain
which do not have a 2D barcode by February
2019
• These can still be dispensed
• They are not required to be
decommissioned
Can we still dispense PI medicines?
• Yes
• PIs will be re-packaged and re-labelled for the
intended country
• This includes a new UI and barcode and ATD (if
required)
• Brexit may impact the position of
parallel traded products
I have a Wholesale Dealers License – do
I have additional FMD requirements?
• Pharmacies with a WDL will be required to
meet both the requirements for pharmacies and
wholesalers
• This will require a number of additional steps
• It is advisable to become familiar with the
Deregulated Regulation (2016/161)
FMD equipment
• Pharmacies will be responsible for any costs
associated with obtaining or updating software
and hardware
• Stand alone systems
• PMR integrated systems
FMD Connect
• Stand alone system
• Business partner with the NPA.
• www.fmd-it.co.uk
NPA Resources
• Webinar 15/10/2018
• SOPs coming soon
Getting Started
• Update existing IT system and hardware
or install a new stand alone FMD system
• Get connected to the verification system
• Revise workflow and SOP’s
• Staff training
• Information material for patients
Questions
Thank you!